Lebikizumab

Indications

Lebikizumab is used for: Atopic Dermatitis

Adult Dose

Subcutaneous Injection Single-use pre-filled pen contains 250 mg of lebrikizumab in 2 mL solution (125 mg/mL). Atopic Dermatitis Indicated for the treatment of moderate-to-severe atopic dermatitis in adults The recommended dose of lebrikizumab is 500 mg (two 250 mg injections) at both week 0 and week 2, followed by 250 mg administered subcutaneously every other week up to week 16. Consideration should be given to discontinuing treatment in patients who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may further improve with continued treatment every other week up to week 24. Once clinical response is achieved, the recommended maintenance dose of lebrikizumab is 250 mg every fourth week. Hepatic impairment No dose adjustment is recommended for patients with hepatic impairment

Child Dose

Subcutaneous Injection Single-use pre-filled pen contains 250 mg of lebrikizumab in 2 mL solution (125 mg/mL). Atopic Dermatitis Indicated for the treatment of moderate-to-severe atopic dermatitis in adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy. The recommended dose of lebrikizumab is 500 mg (two 250 mg injections) at both week 0 and week 2, followed by 250 mg administered subcutaneously every other week up to week 16. Consideration should be given to discontinuing treatment in patients who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may further improve with continued treatment every other week up to week 24. Once clinical response is achieved, the recommended maintenance dose of lebrikizumab is 250 mg every fourth week.

Renal Dose

Renal impairment No dose adjustment is recommended for patients with renal impairment

Administration

Subcutaneous use. Lebrikizumab is administered by subcutaneous injection into the thigh or abdomen, except for 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used. For the initial 500 mg dose, two 250 mg injections should be administered consecutively in different injection sites. It is recommended to rotate the injection site with each inj

Contra Indications

Hypersensitivity to the active substance or to any of the excipients.

Precautions

Hypersensitivity If a systemic hypersensitivity reaction (immediate or delayed) occurs, administration of lebrikizumab should be discontinued and appropriate therapy initiated. Conjunctivitis Patients treated with lebrikizumab who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination. Helminth infection Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if lebrikizumab will influence the immune response against helminth infections by inhibiting IL-13 signalling. Patients with pre-existing helminth infections should be treated before initiating treatment with lebrikizumab. If patients become infected while receiving lebrikizumab and do not respond to antihelminth treatment, treatment with lebrikizumab should be discontinued until infection resolves. Vaccinations Prior to initiating therapy with lebrikizumab, it is recommended that patients are brought up to date with all age-appropriate immunisations according to current immunisation guidelines. Live and live attenuated vaccines should not be given concurrently with lebrikizumab as clinical safety and efficacy has not been established. Immune responses to non-live vaccines were assessed in a combined tetanus, diphtheria and acellular pertussis vaccine (TdaP) and a meningococcal polysaccharide vaccine.

Pregnancy-Lactation

Pregnancy There are limited amount of data from the use of lebrikizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of lebrikizumab during pregnancy. Breast-feeding It is unknown whether lebrikizumab is excreted in human milk or absorbed systemically after ingestion. Maternal IgG is known to be present in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from lebrikizumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility Animal studies showed no impairment of fertility

Interactions

Adverse Effects

Side effects of Lebikizumab : The most common adverse reactions are conjunctivitis (6.9%), injection site reactions (2.6%), conjunctivitis allergic (1.8%) and dry eye (1.4%). Uncommon: Herpes zoster, Eosinophilia, Keratitis, Blepharitis

Mechanism of Action

Lebrikizumab is an immunoglobulin (IgG4) monoclonal antibody that binds with high affinity to interleukin (IL)-13 and selectively inhibits IL-13 signalling through the IL-4 receptor alpha (IL-4Rα)/IL-13 receptor alpha 1 (IL-13Rα1) heterodimer, thereby inhibiting the downstream effects of IL-13. Inhibition of IL-13 signalling is expected to be of benefit in diseases in which IL-13 is a key contributor to the disease pathogenesis. Lebrikizumab does not prevent the binding of IL-13 to the IL-13 receptor alpha 2 (IL-13Rα2 or decoy receptor), which allows the internalisation of IL-13 into the cell.